Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics. It’s been a minute, let’s get you caught up:
Veterans Affairs continues to drive federal psychedelic push
I got to ask U.S. Department of Veterans Affairs Secretary Doug Collins a few questions during his visit to Seattle’s VA Medical Center on August 7. He re-iterated that ibogaine would be the agency’s next emphasis. Ibogaine is a psychoactive compound that comes from the Tabernanthe iboga shrub, which grows in equatorial Central and West Africa. Researchers have also synthesized ibogaine in a laboratory. Collins acknowledged that federal sourcing for ibogaine is still a work in progress. “Ibogaine is not available in the United States until we get the protocols,” Collins said. “We’re actually hopeful to get some cooperation. You know, within the realms of discussion with those that are across the border.”
Collins also revealed his agency is collaborating with the U.S. Food and Drug Administration to develop requirements, known as ‘Risk Evaluation and Mitigation Strategies,’ to help address ibogaine’s cardiac risks. “It’s going to be safe when we do it with our veterans. That’s our key,” Collins said. “That’s why FDA is doing an accelerated study.”
Collins also highlighted a recently announced multi-site VA trial testing psilocybin for treatment-resistant depression. News of the trial initially became public in November 2025, and recruitment is expected to begin soon at five VA locations across the country. Of note, Compass Pathways’ synthetic, proprietary formulation of psilocybin, called COMP360, will be used in the trial. Psychedelic Alpha’s analysts are speculating this choice may signal that federal agencies, including the VA, may eventually help companies like Compass by streamlining the drug’s expansion in psychiatry.
Other moves that are expected to drive the VA’s push into psychedelic research include a July Memorandum of Understanding among the agency, FDA, and the U.S. Department of Health and Human Services (HHS). It lays out a framework for collaboration and information exchange to advance President Trump’s April Executive Order. Also in July, the U.S House of Representatives passed a bill containing psychedelics amendments that would direct the VA to submit progress reports on the executive order and designate an official to oversee work on “emerging therapeutic interventions.”
New FDA guidance on psychedelics
New guidance released by the Food and Drug Administration in July details the agency’s recommendations for clinical investigators studying psychedelics for medical conditions. It follows the agency’s first draft guidance that was released in 2023. Key parts of the guidance remain the same, but there are notable updates.
For example, the FDA provided more clarity on what regulators are looking for in trial populations, safety assessments, and long-term follow ups. In an ‘Abuse Potential Assessment’ section, the agency clarifies that experiences like euphoria and hallucinations should be documented as adverse events, even if trial participants don’t describe them as harmful. Regulators also updated recommendations for control groups and functional unblinding. Traditional placebos might be eliminated in favor of lower doses of the psychedelic or drugs that have psychoactive effects, the agency suggests. “In general, controls should be closely matched to the treatment group for clinically relevant variables and clinical care,” the guidance reads. The document also states the most informative trial would include a blinded 12-month follow up, which is a longer duration than many clinical trials.
In making recommendations around trial populations, regulators said trial cohorts should be “reasonably representative” of the population that will end up using the treatment. Also, investigators also shouldn’t exclude people based on their age or treatment history who could be prescribed the intervention post-approval. Regulators add that people who have used psychedelic drugs before “should not be overrepresented.”
The FDA and Health and Human Services are requesting public input on the final guidance. There’s a hearing scheduled for September 14, and people can submit written comments through October 5. Specifically, federal leaders want feedback on “(1) provider training and credentialing, (2) promotion of patient safety, (3) considerations for access, and (4) best practices for data collection and standardization.” Those interested in participating can register via the FDA website.
Resilient Pharmaceuticals tries again for FDA approval of MDMA
In a statement released August 10, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) seemed to indicate the updated FDA guidelines will help advance MAPS’s decades of research on MDMA-assisted therapy. In 2024, the FDA declined the application for MDMA-assisted therapy for PTSD from Lykos Therapeutics, the psychedelic drug company that grew out of MAPS and later changed its name to Resilient Pharmaceuticals. According to Lykos’s press release after the agency’s rejection, the FDA requested a new Phase 3 trial, an endeavor that would have taken years to complete and that suggested regulators had real issues with the evidence submitted by Lykos.
MAPS’s statement confirmed that Resilient Pharmaceuticals recently resubmitted a new drug application (NDA) to the FDA for MDMA-assisted therapy. “Two years after FDA rejected the initial application for MDMA-assisted therapy for PTSD, Resilient’s new NDA is being submitted without a new Phase 3 study,” said MAPS founder Rick Doblin in the August 10 statement. MAPS leaders added that the new FDA guidance aligns with what they’ve already been doing. “We knew the FDA wasn’t saying no, just not yet,” said Doblin.
Pharmaceutical giant Eli Lilly makes a psychedelics acquisition
Last month, the Indianapolis-based Eli Lilly and Company, a pharmaceutical giant with the most prescription drug sales globally, acquired New York-based psychedelic biopharmaceutical company AtaiBeckley Inc. for $2.8 billion up front. The deal follows the Japanese pharmaceutical company Otsuka’s acquisition of Transcend Therapeutics, Inc in March and AbbVie’s acquisition of Gilgamesh Pharmaceuticals’ psychedelic compound GM-2505, or bretisilocin, in 2025. Bretisilocin is chemically similar to DMT, but engineered to provide a roughly two-hour trip.
Lilly’s purchase of AtaiBeckley is one of many recent acquisitions by the company, amidst soaring sales of its GLP-1 weight loss treatments. With the purchase, the company gets Atai’s BPL-003, a synthetic nasal form of 5-MeO-DMT with FDA Breakthrough Therapy Designation, positioned to enter Phase 3 clinical trials. AtaiBeckley will also bring Lilly VLS-01, a form of DMT that dissolves in the cheek. Both BPL-003 and VLS-01 are being tested for treatment-resistant depression, and both are fast acting, with their psychedelic effects fitting into a two hour clinic session. “If both agents move through the clinic quickly, Lilly could pay an additional $1 billion to AtaiBeckley shareholders,” Nature reports, bringing the total purchase price up to $3.8 billion.
AtaiBeckley is also developing an MDMA drug candidate called EMP-01. MDMA is typically a “racemic mixture,” meaning it contains an equal proportion of two components, known as R-MDMA and S-MDMA, which are mirror images of each other. AtaiBeckley’s EMP-01 is a formulation of only R-MDMA. Previous research has suggested that S-MDMA is associated with strong visual effects and higher blood pressure. In February, AtaiBeckley announced preliminary results from a Phase 2a clinical trial using EMP-01 to treat social anxiety.
Needham and Company biotech analyst Ami Fadia told CNBC that companies like Eli Lilly are following in the footsteps of Johnson & Johnson’s Spravato esketamine nasal spray, which has served “as the market model” for pharmaceutical companies wanting to get into psychedelics. Forbes reports that Spravato annualized close to $2 billion in sales for depression treatments. “A few years ago, some investors would not want to touch [psychedelics], but now I rarely hear that,” Fadia told CNBC.
Eli Lilly buying AtaiBeckley marks a big move in the market but it doesn’t mean that other companies and other compounds will be left behind, Jefferies analyst Andrew Tsai told CNBC. “Big picture, I don’t think this is a winner-take-all market by any means. When you look at history, multiple SSRIs can become blockbusters, multiple antipsychotics can become blockbusters. So I do think multiple [psychedelics] players can win,” Tsai said. The Microdose reached out to Eli Lilly for comment but did not get a reply.
Ibogaine puts cardiovascular safety top of mind for researchers
Ibogaine’s profile has risen in recent months with state and federal attention, and researchers are trying to better understand the drug’s known cardiac risks. A recent study out of Brazil published by Trends in Psychiatry and Psychotherapy describes an ibogaine pilot trial testing the drug’s feasibility and safety in nine patients with alcohol use disorder. Of the five patients that completed the study, most reported reduced alcohol use. But the authors urge caution in future randomized, controlled trials that will be needed to validate ibogaine’s therapeutic potential. “Moderate doses of ibogaine showed a cardiotoxic potential that demands rigorous cardiovascular screening and continuous monitoring,” the researchers write.
Legal experts have also flagged ibogaine’s cardiac risks. On July 20, the American Bar Association published an article with recommendations for litigation-ready trial design. “For ibogaine, where cardiac risk is established in the literature, the failure to implement appropriate monitoring may constitute negligence regardless of whether a specific event was anticipated in an individual participant,” authors write.
A review published August 1 in the European Journal of Clinical Pharmacology assessed cardiovascular safety in psilocybin trials and studies posted through July 10. Psilocybin has a different, less severe cardiac risk profile than ibogaine but can also increase heart rate and blood pressure.
Meta-analyses within the review found a moderate, transient increase in blood pressure in psilocybin trials. While serious, acute cardiovascular events were uncommon in screened trial participants, “the evidence should not be generalized unchanged” to future sessions involving older adults, those with cardiovascular disease, and other drug interactions, the authors write. Overall, the authors suggest that current regulated, monitored trials in select populations are safe – and make recommendations to keep them that way. However, they stress, the evidence does not support “general cardiovascular reassurance across all products, exposure patterns, or psychiatric settings.”
A coder in Sweden created a chatbot plug-in to make AI models seem high on weed, coke or ketamine, The World’s Gerry Hadden reports.
Definium Therapeutics announced Wednesday promising results from a Phase 3 study testing its proprietary oral formulation of LSD, DT120, for generalized anxiety disorder.
‘Spiritual psychiatrist’ Samuel Lee is being charged with manslaughter following the death of one of his clients at a Miami retreat. According to court documents, the medical examiner’s office ruled the client’s cause of death was “hyponatremic dehydration due to confinement in a sauna, and use of Methylenedioxymethamphetamine [MDMA] and ketamine.” In a recent post, writer Jules Evans wonders if underground guides understand the legal risks of their profession.
In a perspective published August 6 in npj Mental Health Research, psychedelic researchers call for well-being to be a trial endpoint, instead of simply using symptom reduction to define success.
Scientific American highlighted clinics that are being stood up to treat harmful post-trip conditions that are rare but lasting.
Writer and Ferriss-UC Berkeley Psychedelic Journalism fellow Michelle Lhooq asks “Are Psychedelics Right-Wing Now?” in the New Yorker.
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